SUPPLY CHAIN ARTICLES
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![mirror, your true self-GettyImages-1264700812]( "\"Mirror, Mirror…\": Reflections On Reducing mRNA Production COGS")
"Mirror, Mirror…": Reflections On Reducing mRNA Production COGSHere, I outline three overarching words of wisdom I gleaned from Life Edit Therapeutics’ April Sena; Tune Therapeutics’ Tyler Goodwin; and University of Sheffield’s Adi on how the mRNA/RNA industry can better control production costs — particularly as it relates to raw material sourcing and usage.
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![Business Unity-GettyImages-1253212054]( "The RNA Therapeutics Supply Chain: A Platform of Relationships")
The RNA Therapeutics Supply Chain: A Platform of RelationshipsConversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.
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![Key takeaways-GettyImages-1659816694]( "Plasmid Production: 3 Key Takeaways For mRNA Manufacturing")
Plasmid Production: 3 Key Takeaways For mRNA ManufacturingFollowing my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid.
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![women gossiping-GettyImages-72131155]( "A \"Hot Take\" on Personalized mRNA Medicines")
A "Hot Take" on Personalized mRNA MedicinesmRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.
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![Helping Hand-GettyImages-1314188794]( "Multidisciplinary mRNA: What Can We Learn From Other CGTs?")
Multidisciplinary mRNA: What Can We Learn From Other CGTs?Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.
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![biotechnology, Global Networking, Research, Development, Innovation, Advancing Smart Solutions-GettyImages-2123154659]( "Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control")
Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle ControlOligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.
SUPPLY CHAIN VIDEOS
Together, this Advancing RNA panel briefly addresses the ongoing rise of synthetic pDNA, sharing the current benefits and limitations of working with this technology for plasmid production today.
There remain a lot of gaps in our understanding of plasmid quality, particularly for high-quality mRNA production (as opposed to viral vector production). In this segment of a recent Advancing RNA Live panel, speakers Adi Nair, Tyler Goodwin, and April Sena highlight their biggest questions around plasmid DNA quality, as well as the pros and cons of some of the analytical methods upon which we’re relying most heavily today to assess plasmid quality.
Large scale production of plasmid DNA requires an in-depth understanding and optimization of the entire downstream process. Explore a complete solution, from harvest to bulk filtration.
In this opening Advancing RNA Live clip, NanoVation Therapeutics’ Dominik Witzigmann and Stealth Co’s John Zuris share the scientific advancements they’ve been watching most keenly in the LNP space, as well as some of the evolutions they’re seeing in the overall quality of our RNA-LNP products.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1357908552]( "Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing")
Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.
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![Scientists laboratory pipette GettyImages-621351044]( "Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs")
Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
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![Merck Building-shmear]( "Biopharma Supply, Reimagined: Regional, Resilient Manufacturing")
Persistent disruption is redefining biopharma supply chains. Explore how regional manufacturing, integrated risk management, and closer collaboration help build resilience and improve agility.
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![GettyImages-1459917555-lab-research-development-gene-genetic]( "Mastering mRNA Manufacturing: A Focus on Raw Materials & Supply Assurance")
Rapid advancements in mRNA-based therapeutic development have underscored the role of raw material quality and supply chain management in ensuring their successful production.
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![GettyImages-155372946-cold-chain-cryopreservation-logistics]( "Supercharge Your Supply Chain: Harness AI To Gain Competitive Advantage")
The success of CGTs hinges upon adherence to specific logistics protocols. Learn how the integration of AI in the pharma supply chain is poised to enhance visibility, efficiency, and compliance.
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![GettyImages-1288118586 cell development]( "Expectations On The Pathway To GMP For Gene-Modified Cell Therapies")
Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
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![Thermo ABM pic]( "Delivering Global Media Manufacturing Consistency Through Site-To-Site Equivalency")
Explore a program focused on achieving process consistency through risk mitigation in four key areas: raw materials sourcing, equipment, manufacturing processes, and finished product testing.
